Final EPOS Study results published
Posted in Neurology News on 1st Mar 2016
Eisai have announced final results of the European non-interventional study EPOS (Eslicarbazepine acetate in Partial-Onset Seizures) in epilepsy journal Acta Neurologica Scandinavica.
Results show that once-daily eslicarbazepine acetate can provide a significant decrease in seizure frequency and seizure freedom in many patients, and is well tolerated in clinical settings. The responder rate (proportion of patients with seizure reduction of 50% and above vs. baseline) at six months was 81.8%, with 39.2% of patients reporting seizure freedom. The retention rate after 6 months was high with 82.2%. Over the 6 month study period, the score of the quality of life inventory QOLIE-10 improved from 2.9 at baseline to 2.1 at study end, on group level.
EPOS is a non-interventional, multicentre, prospective study with adult patients suffering from partial-onset seizures insufficiently controlled by antiepileptic monotherapy (n=247). Retention, tolerability and safety, efficacy, as well as effects on health-related quality of life of eslicarbazepine acetate as only add-on therapy were assessed.
The study was conducted in eight European countries (UK, Ireland, Denmark, Sweden, Norway, France, Czech Republic and Germany).1 “The results show that with this add-on treatment, we can offer patients with focal epilepsy inadequately controlled by monotherapy a chance to improve their condition. The high retention rate reflects treatment satisfaction, and points to an efficacious and well tolerable therapy, which is easy to initiate.
Approximately one third of people with epilepsy do not achieve seizure freedom with monotherapies, so there is a continued need for additional efficacious treatment options,” comments Martin Holtkamp, Principal Investigator, University Hospital Charité, Germany.
Eslicarbazepine acetate, indicated in Europe as adjunctive therapy in adults with partial-onset seizures, with or without secondary generalization[ii] is a once-daily drug and exerts its effect by a differential and selective action of its primary metabolite, eslicarbazepine, on sodium channels in their slow inactivated state. Eslicarbazepine acetate was approved by the European Commission in 2009 based on data submitted which showed that a significant therapeutic response could be reached by up to to 44% of difficult-to-treat patients with partial epilepsy.[iii] In long-term studies in patients with refractory epilepsy, it was shown that seizure freedom could be achieved by up to 12,5% of patients.[iv] Furthermore, experimental evidence documents an effect of eslicarbazepine in human brain tissue refractory to carbamazepine.[v]
Epilepsy is one of the most common neurological conditions, affecting approximately 6 million people in Europe.[vi] Despite many anti-epileptic drugs (AEDs) available, the successful treatment of partial onset seizures remains a significant challenge in some patients. Currently, between 20–40% of patients with newly diagnosed epilepsy will become refractory to treatment.[vii]
[i] Holtkamp et al. Eslicarbazepine acetate as add-on treatment to antiepileptic monotherapy in adults with partial-onset seizures: real-world data on retention, dosing, patient reported seizure outcome and safety from an interim analysis of the open-label non-interventional study EPOS. Acta Neurologica Scandinavica 2016. Available at http://onlinelibrary.wiley.com/doi/10.1111/ane.12574/full (accessed February 2016)
[ii] Eisai Ltd 2015. Zebinix® (eslicarbazepine acetate) summary of product characteristics (last updated May 2015): http://www.medicines.org.uk/emc/medicine/22376/SPC/Zebinix+800mg+tablets/
[iii] Gil-Nagel A et al. Efficacy and safety of eslicarbazepine acetate as add-on treatment in patients with focal-onset seizures: integrated analysis of pooled data from double-blind phase III clinical studies. Epilepsia 2013;54(1):98-107
[iv] Halász P, Elger C, Guekht A, et al. Long-term efficacy and safety of eslicarbazepine acetate: Results of a 1-year open-label extension study in partial-onset seizures in adults with epilepsy. Epilepsia, 51(10):1963–1969, 2010
[v] Doeser et al. Targeting pharmacoresistant epilepsy and epileptogenesis with a dual-purpose antiepileptic drug. Brain 2014;1:1
[vi] ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe 2010. Available at; http://www.ilae.org/Visitors/Documents/ILAEAnnual-Report2010Final_000.pdf (Accessed January 2015)
[vii] French JA. Refractory Epilepsy; Clinical Overview. Epilepsia 2007; 48 (Suppl1) 3-7
[viii] Almeida L, Soares-da-Silva P. Eslicarbazepine Acetate (BIA 2-093). Neurotherapeutics 2007 Jan; 4(1):88-96
[ix] Elger C et al. Pharmacokinetics and tolerability of eslicarbazepine acetate and oxcarbazepine at steady state in healthy volunteers. Epilepsia 2013; 54(8):1453-1461
[x] Hebeisen S et al. Eslicarbazepine and the enhancement of slow inactivation of voltage-gated sodium channels: a comparison with carbamazepine, oxcarbazepine and lacosamide. Neuropharmacology 2015 Feb; 89:122-135. Doi 10.1016/j.neuropharm.2014.09.008.
[xi] Vilin YY and Ruben PC. Slow Inactivation in Voltage-Gated Sodium Channels. Cell Biochem Biophys 2001; 35(2):171-190
[xii] Elger et al. Eslicarbazepine Acetate: A Double-blind, Add-on, Placebo-controlled Exploratory Trial in Adult Patients with Partial-onset Seizures. Epilepsia 2007; 48(3):497-504
[xiii] Ben-Menachem E et al. Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy; Epilepsy Research 2010; 89:278-285
[xiv] Pugliatti M, et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007; 48(12) 2224-2233